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CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas

Sponsor
Chinese PLA General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT02259556
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
180
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Chimeric antigen receptor-modified T cells (CART) holds great promise for treatment of tumors. In this trial, CD30 positive Hodgkin's lymphoma and Non-Hodgkin's lymphoma will be treated by CD30-specific CART cells (CART30).

Condition or Disease Intervention/Treatment Phase
  • Biological: CART30
 Phase 1/Phase 2

Detailed Description

When patients enroll on this trial, autologous CART-33 cells were generated from the mononuclear cells of 50 to 90 ml of the patient's peripheral blood (PB). During the term of cell preparation of CART30, patients will receive a conditioning regimen including cyclophosphamide and fludarabine. One day after completing conditioning regimen, the patient will be given infusions of CART30 cells into the vein in escalating doses over a period of 3 to 5 consecutive days.

Extra blood will be drawn to measure the persistence of CART30 in vivo.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
CD30-directed Chimeric Antigen Receptor T (CART30) Therapy in Relapsed and Refractory CD30 Positive Lymphomas
Study Start Date :
Oct 1, 2014
Anticipated Primary Completion Date :
Oct 1, 2018
Anticipated Study Completion Date :
Oct 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: anti-CD30 CAR T cells

Patients receive CART30 cell infusions with an escalation dose.

Biological: CART30
Cells will be infused 1 day after the completion of conditioning regimen.
Other Names:
  • anti-CD30 CAR T cells

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Occurrence of related adverse events [untill week 24]

    Secondary Outcome Measures

    1. Anti-tumor response to CART30 cell infusions [Up to 24 weeks]

      Evaluated mainly by computed tomography scanning

    Other Outcome Measures

    1. in vivo existence of CART30 [1 year]

      Measure mainly by the changes of CAR molecule levels in blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    16 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male and female subjects with CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma relapsing after autologous stem-cell transplantation (ASCT), or refractory to 2 multidrug regimens and/or anti-CD30 antibody treatment.

    • Newly diagnosed CD30+ Hodgkin lymphoma and Non-Hodgkin lymphoma patients who are unable to receive or complete standard chemotherapy.

    • Karnofsky or Lansky score greater than 60%.

    • Expected survival>12 weeks.

    • Creatinine<2.5mg/dl.

    • ALT (alanine aminotransferase)/AST (aspartate aminotransferase)<3 fold normal.

    • Bilirubin<2.5mg/dl.

    • Pulse oximetry of >90% on room air.

    • Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin.

    • Available autologous T cells with 10% or more expression of CD30 CAR determined by flow-cytometry.

    • Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.

    Exclusion Criteria:

    • Active infection such as hepatitis B or C.

    • Receive anti-CD30 antibody-based therapy within recent 6 weeks.

    • Current use of systemic corticosteroids.

    • Pregnant or lactating.

    • Confirmed tumor in pulmonary and archenteric tissues.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Chinese PLA General Hospital Beijing Beijing China 100853

    Sponsors and Collaborators

    • Chinese PLA General Hospital

    Investigators

    • Study Chair: Weidong Han, Ph.D, Chinese PLA General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Han weidong, Director, Chinese PLA General Hospital
    ClinicalTrials.gov Identifier:
    NCT02259556
    Other Study ID Numbers:
    • CHN-PLAGH-BT-011
    First Posted:
    Oct 8, 2014
    Last Update Posted:
    Jan 28, 2016
    Last Verified:
    Jan 1, 2016
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Jan 28, 2016